Minimally Invasive Aortic Valve Replacement for Aortic Stenosis: Edwards Valve

Author: Michigan Medicine

As the American population ages, as we hit the baby boom years and that population evolves into the elderly life span, those patients are going to be increasingly faced with the burden of aortic stenosis. Patients with symptomatic severe aortic stenosis have a significantly impaired quality of life. Symptoms associated with severe aortic stenosis can include shortness of breath or loss of breath with exertion, chest discomfort, chest tightness or heaviness with exertion. They can even suffer light headedness and even sometimes pass out associated, often again, with exertion. This is a big group of patients.

We can estimate there may be as much as 300,000 patients with aortic stenosis every year in this country. That are emendable to some form of [inaudible] aortic valve. Unfortunately once patients suffer symptoms associated with severe aortic stenosis, not only is there quality of life impaired, but actually their expected quantity of life is significantly shortened. Fifty percent of patients who are symptomatic from severe aortic stenosis, who are treated medically, will expire within one year.

Over 75 percent in two years. And the likelihood of living three years is almost zero. And so when you have patients who are really sick with aortic stenosis, you have to perform some form of intervention. It's a mechanical problem requires a mechanical solution. Aortic stenosis is typically treated with open-heart surgery. Very few things in medicine give the outcomes that surgical aortic valve replacement did. But not everybody's a candidate for conventional aortic valve replacement.

But what we're trying to do is augment that with a less invasive procedure that will get us same results with less of an impact or insult on the patient. It won't impinge on the quality of life like an open procedure does. And we can deliver it there to a patient population that before didn't receive therapy. Can I safely offer this patient open-heart surgery? Would I consider this patient for open-heart surgery? And if the answer is no, that was the objective evidence makes the answer very simple. Those patients should be considered for Percutaneous Valve technologies. Here at the University of Michigan, you can see we feel very privileged to have both Percutaneous Valve technologies available to us. The Medtronic Core Valve and the Sapien Edwards Valve.

Minimally Invasive Aortic Valve Replacement for Aortic Stenosis: Edwards Valve

They both have the same function to replace diseased aortic valve by a percutaneous method be it from the femoral area, [inaudible] or even direct aortic approach. The Transcutaneous Edwards valve is actually, basically, the same valve as the implantable valve that we use. It's made of three leaflets.

And in the implantable, the one that we use for open surgery, they put it in a ridged stent or holder, and the three leaflets are placed within that holder. The holders placed within the aortic at the base where the valve sits. We cut the valve out, the diseased valve, and then we implant this in. Well, for the transcutaneous you can't have that ridged stent because you can't pass that up through the blood vessels, through the tiny blood vessels moving up. So what they do is, they put the same three leaflets in a flexible, expandable metal stent cage.

And then they compress it down around a catheter with a balloon in it. And then we pass that up through a peripheral vessel, most commonly in the groin, pass it up through larger vessels into the aorta, down in through the valve. We put a separate balloon up first and then we blow the valve up, so that the calcified ridged doors are expanded open. And then we sat the new valve down inside and deploy or expand the new valve in using the balloon within the valve catheter.

The joy of having this technology is being cognizant of the fact that we now have something to offer these patients. Once patients recover from their procedure, their expected quantity of life is the same as patients who don't have aortic stenosis. These patients are brought down to the room for this procedure. They're on oxygen. They're huffing and puffing. They're an extreme. And you do this procedure on them and you wake them up and you extubate them and they're breathing fine.

And, you know, they're happy. They can eat and they can speak in complete sentences and they want get up and move around and do thing that they couldn't do before. So it has a tremendous impact. And the data we have from Europe is outstanding. Patients are doing extremely well. And without any significant deterioration or dysfunction of the valves that have been placed transcutaneously What getting the Percutaneous Valve technology did for the University of Michigan, is that it added almost a last piece that we needed to deliver comprehensive care for patients with disease spanning from the aortic valve all the way through to the terminal aorta. Who wouldn't rather come in and have this procedure and go home in three days and return to their lifestyle like they had a hernia operation, verses an open-heart surgery where it takes you several months to recover? And so this is huge for the patients. One of the foundations of the Cardiovascular Center here at the University of Michigan is the fact that we do work closely together to take care of our patients.

We don't talk about my case or your case. We talk about our patient and how we're going to do the best to take care of that patient and provide them with the best possible outcome. Our goal is to deliver care to your patient and get your patient back to you. And I think having access to this technology allows us to treat patients who may be older or may be somewhat sicker or still struggling from the effects of valve disease are not candidates for conventional therapies. But are suitable for a less invasive approach, in order to get them back to a normal quality of life.

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